France’s Inserm in Talks With Guinea on Ebola Trials

Aug. 29 (Bloomberg) -- France’s state health institute,
Inserm, is in talks with Guinea authorities on the first
clinical trials of experimental Ebola therapies on patients ill
with the virus in the West African country.

Inserm is considering two trials, each involving at most 15
patients, to test compounds from Fujifilm Holdings Corp. and
Tekmira Pharmaceuticals Corp., said Jean-Francois Delfraissy,
director of Inserm’s Institute of Microbiology and Infectious
Diseases. Discussions with Guinea officials began this week and
no decision has been made, he said.

“We are at the stage of starting to talk with authorities,
to see whether this can potentially be done, for patients who
don’t have too many symptoms yet,” Delfraissy said in a
telephone interview today.

Inserm’s possible trials would add to the race to develop
treatments for Ebola, which has infected more than 3,000 people
and killed more than 1,550 in Liberia, Sierra Leone, Guinea and
Nigeria in this outbreak. The epidemic is on a pace to kill more
people than all previous Ebola outbreaks combined, and the World
Health Organization declared it a global health emergency, that
could eventually infect 20,000.

Senegal reported its first case today, a 21-year-old
college student from Guinea. The country is now the fifth in
West Africa to confirm the presence of Ebola. A separate,
unrelated outbreak was reported in the Democratic Republic of
Congo this week.

Scientists at the U.S. National Institutes of Health’s
Vaccine Research Center plan to begin enrolling patients next
week in an early-stage trial of GlaxoSmithKline Plc’s
experimental Ebola vaccine. Another experimental drug made by
Mapp Biopharmaceutical Inc., ZMapp, has been used to treat
health workers who fell ill while caring for Ebola patients.

In a trial in monkeys, 18 of the animals that got ZMapp
after being infected with Ebola for three to five days survived,
while three monkeys who didn’t get the drug died, according to
results published today in the journal Nature.

Mid-Stage Trials

Sakoba Keita, head of the epidemic prevention unit at
Guinea’s Health Ministry, confirmed that Guinea is in talks with
France on the experimental Ebola treatments. “There has been as
yet no letter of formalization, but an agreement in principle
has been obtained,” Keita said by phone today.

Representatives at Tekmira and Fujifilm didn’t immediately
respond to requests for comment. The U.S. Food and Drug
Administration said Aug. 8 that Tekmira’s TKM-Ebola treatment
could be given to infected people. U.S. researchers are working
to get Fujifilm’s flu drug favipiravir approved for use in
humans with Ebola. The medicine is being tested in monkeys, with
preliminary data expected in mid-September.

The two mid-stage trials contemplated by Inserm would be
designed to show whether the compounds have an “anti-Ebola
activity on human beings, which we don’t know yet right now,”
Delfraissy said during the interview. They won’t start for at
least two months, he said. Another trial, testing a combination
of different compounds, could be considered later, he said.

WHO Discussions

Inserm also is discussing the trials with the Geneva-based
WHO and Doctors Without Borders, Delfraissy said. The French
institute may consider moving on to other countries later,
Delfraissy also said.

“For now, it’s Guinea,” he said. “If we were to go
elsewhere afterward it would be Liberia, where the situation is
even more complicated. We have contacts there as well, with
clinicians, but we have had no contact with Liberian
authorities.”

Ebola is spread through direct contact with bodily fluids
from an infected person. It causes fever, diarrhea, muscle pain,
vomiting and, as it progresses, can lead to bleeding from the
eyes, ears and nose. In the past, the fatality rate has been as
high as 90 percent. About 52 percent of those infected in the
current outbreak have died.

There’s no approved drug for the illness. Doctors treat
patients by keeping them hydrated, replacing lost blood and
using antibiotics to fight off opportunistic infections. The
goal is for the body’s immune system to eventually beat the
disease.

“People are waiting for help, for results, and for the
time being we don’t have the products yet,” Delfraissy said.

The number of people falling ill is accelerating, and more
than 20,000 people may be infected with Ebola before the
outbreak in West Africa is controlled, the WHO said yesterday.

“It’s important to remain cautious because there are too
many announcements on Ebola right now,” Delfraissy said.